Cleared Traditional

K203497 - Infrared Thermometer (Model K9)

K203497 is an FDA 510(k) clearance for Infrared Thermometer (Model K9), manufactured by Kangzhan Communication Electronics Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K203497 · Kangzhan Communication Electronics Co., Ltd. · General Hospital
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Oct 2021
Decision
315d
Days
Class 2
Risk

K203497 is an FDA 510(k) clearance for the Infrared Thermometer (Model K9). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Kangzhan Communication Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 8, 2021 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kangzhan Communication Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K203497

510(k) Number K203497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2020
Decision Date October 08, 2021
Days to Decision 315 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 129d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 372
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K203497.
Infrared forehead thermometer LD-FT-100B
K211629 · Honsun (Nantong) Co., Ltd. · Dec 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · Health & Life Co., Ltd. · Nov 2021
Phoenix Digital Thermometer
K201032 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Oct 2021
ThermArt (Model IR-EFT)
K202481 · Comper Chuangxiang (Beijing) Technology Co., Ltd. · Sep 2021
DT100 Digital Thermometer
K203731 · Smart Technology Co., Ltd. · Sep 2021
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
K203662 · Yibin Junxin Electronics Technology Co., Ltd. · Sep 2021